At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 102 enrolled
Drug / intervention
RSV vaccine GSK3003891A +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Observer-blind Safety and Reactogenicity Study to Assess GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women
In Brief
A Phase 2 clinical trial evaluating RSV vaccine GSK3003891A and Boostrix for Respiratory Syncytial Virus Infections. Completed, enrolled 102 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the safety and reactogenicity of a single intramuscular dose of GSK Biologicals' investigational RSV vaccine, in healthy, non-pregnant women aged 18 to 45 years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections
CountriesBelgium
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartApr 2016
First PostedApr 2016
Primary CompletionJun 2016
TodayJul 2026
First PostedApr 27, 2016
Enrollment StartApr 1, 2016
Primary CompletionJun 28, 2016
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.2 years ago
Interventions
RSV vaccine GSK3003891Abiological
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
Boostrixbiological
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.